Devices and methods for crimping a medical device

ABSTRACT

Devices, systems, and methods for crimping a medical device are disclosed. More specifically, the present disclosure relates to devices, systems, and methods for reducing the diameter of a collapsible heart valve prosthesis to be loaded onto a delivery device. The devices, systems, and methods using at least one funnel to crimp the heart valve prosthesis and load it onto the delivery system.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application makes reference to, claims priority to, andclaims benefit from U.S. Provisional Application Ser. No. 61/822,601,which was filed on May 13, 2013. The disclosure of ProvisionalApplication Ser. No. 61/822,601 is incorporated herein in its entirety.

BACKGROUND Field

The present disclosure relates to devices, systems, and methods forcrimping a medical device. More specifically, the present disclosurerelates to devices, systems, and methods for reducing the diameter of acollapsible heart valve prosthesis to be loaded onto a delivery device.

Background

Minimally invasive approaches have been developed to facilitatecatheter-based implantation of valve prostheses in a beating heart,intending to obviate the need for the use of classical sternotomy andcardiopulmonary bypass. An expandable prosthetic valve can be compressedabout a catheter, inserted inside a lumen within the body, such as thefemoral artery, and delivered to a desired location in the heart.

Heart valve prostheses used in these procedures can have aself-expanding multi-level frame that supports a valve body having aplurality of leaflets. The frame can be contracted during percutaneoustransluminal delivery and expanded upon deployment within the nativeheart valve.

In order to compress the frame of the valve prosthesis, crimpingtechniques can be employed to transition the prosthesis from its naturalexpanded state to a compressed state. The compressed prosthesis can thenbe loaded onto or into a delivery device.

BRIEF SUMMARY

The present disclosure relates to devices, systems, and methods forcrimping a heart valve prosthesis. The devices, systems, and methodsprovide uniform, controlled crimping in “reverse” of standard crimpingmethods. Reducing the diameter of the prosthesis in this manner allowsfor minimally invasive delivery to the implantation location.

Generally, the devices, systems, and methods crimp the valve in“reverse.” In certain embodiments, a funnel can be advanced over thesupport arms of the prosthesis first. The support arms can be heldprolapsed proximal to the tip by a metal puller tube. A funnel can bepushed over the support arms and advanced over the inlet of the valve.Once the valve is in a straight section of the funnel, or, for example,a barrel attached to the funnel, the funnel section can be detached andadvanced over the delivery device. In order to crimp the valve down tomatch the inner diameter of the outer sheath of the delivery device, asplit step funnel can be attached to the straight section or barrel. Theinside of the split step can be tapered from the inner diameter of thestraight section of the barrel to the inner diameter of the outer sheathof the delivery device. The outer sheath can be advanced to load thevalve. As the outer sheath is advanced, it can push the split stepfunnel and barrel portion such that the valve moves through the taperedstep and into the outer sheath of the delivery device.

Some embodiments include a system for crimping a prosthetic valve. Thesystem including a first funnel, a second funnel, a delivery device, andan actuator. The first funnel having a first diameter, a taperedsection, and a second diameter smaller than the first diameter. Thesecond funnel having a first diameter, a tapered section, and a seconddiameter smaller than the first diameter. The delivery device includinga strut support and an outer sheath, where at least a portion of thedelivery device configured to extend through the first funnel and thesecond funnel. The actuator being configured to attach to the prostheticvalve and pull the prosthetic valve through at least one of the firstfunnel and the second funnel. The first diameter of the first funnelbeing larger than the first diameter of the second funnel.

In some embodiments, the outer diameter of the outer sheath is less thanor equal to the second diameter of the first funnel and the seconddiameter of the second funnel.

In some embodiments, the first funnel and the second funnel arereleasably connected.

In some embodiments, the system also includes a barrel. The barrel beingconfigured to connect the first funnel to the second funnel. In someembodiments, the barrel includes a first attachment portion forreleasably engaging the first funnel.

In some embodiments, the actuator is a puller tube, the puller tubebeing configured to extend through the first funnel and the secondfunnel. In some embodiments, the actuator includes a handle, a channel,and a pull ring. In some embodiments, the actuator also includes atleast one wire operatively connected to the pull ring. In someembodiments, the actuator is configured to engage to the second funnel.In some embodiments, the actuator is configured to engage to the firstdiameter of the second funnel.

In some embodiments, the system also includes a first tube releasablyconnected to the second diameter of the first funnel, and a second tubereleasably connected to the second diameter of the second funnel. Insome embodiments, the first diameter of the second funnel is configuredto receive at least a portion of the first tube.

In some embodiments, the prosthetic valve is a self-expanding valve.

In some embodiments, the outer sheath is configured to slide over thestrut support.

Some embodiments include a device for crimping a prosthetic valve. Thedevice including a first funnel, a second funnel, and an actuator. Thefirst funnel having a first diameter, a tapered section, and a seconddiameter smaller than the first diameter. The second funnel having afirst diameter, a tapered section, and a second diameter smaller thanthe first diameter. The actuator being configured to attach to theprosthetic valve and pull the prosthetic valve through at least one ofthe first funnel and the second funnel. The first funnel and the secondfunnel being configured to releasably connect to each other and thefirst diameter of the first funnel being larger than the first diameterof the second funnel.

In some embodiments, the device also includes a barrel. The barrel beingconfigured to connect to the first funnel and the second funnel. In someembodiments, the barrel includes a first attachment portion forreleasably engaging the first funnel.

In some embodiments, the first funnel is configured to directly connectto the second funnel. In some embodiments, the second diameter of thefirst funnel is configured to engage the second diameter of the secondfunnel.

In some embodiments, the device also includes a first tube releasablyconnected to the second diameter of the first funnel, and a second tubereleasably connected to the second diameter of the second funnel.

Some embodiments include a method for crimping a prosthetic valve. Themethod including attaching the prosthetic valve to an actuator;advancing a first funnel over the prosthetic valve such that theprosthetic valve moves through the first funnel, the first funnelcomprising a first diameter, a tapered section, and a second diametersmaller than the first diameter; advancing a second funnel over theprosthetic valve such that the prosthetic valve moves into the secondfunnel and onto a strut support of a delivery device, the second funnelcomprising a first diameter, a tapered section, and a second diametersmaller than the first diameter; and advancing an outer sheath of thedelivery device over the prosthetic valve on the strut support. Thefirst diameter of the first funnel being larger than the first diameterof the second funnel.

In some embodiments, the actuator is a puller tube. The puller tubebeing configured to extend through the first funnel and the secondfunnel.

In some embodiments, the first funnel and the second funnel configuredto be releasably connected to a barrel. In some embodiments, the methodincludes attaching the barrel to the first funnel before advancing thefirst funnel over the prosthetic valve; and advancing the prostheticvalve through the first funnel and into the barrel. In some embodiments,the method includes disconnecting the barrel from the first funnel afteradvancing the prosthetic valve into the barrel. In some embodiments, themethod includes connecting the second funnel to the barrel beforeadvancing the second funnel over the prosthetic valve.

In some embodiments, the actuator comprises a handle, a channel, and apull ring. In some embodiments, the actuator also includes at least onewire operatively connected to the pull ring.

In some embodiments, the second diameter of the first funnel isconfigured to engage the second diameter of the second funnel.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying figures, which are incorporate herein, form part of thespecification and illustrate embodiments of crimping devices,techniques, and methods for crimping a prosthetic device. Together withthe description, the figures explain the principals of and allow for themaking and using of the crimping systems and methods described herein.These figures are intended to be illustrative, not limiting. Althoughthe disclosure is generally described in the context of theseembodiments, it should be understood that it is not intended to limitthe scope of the disclosure to these particular embodiments. In thedrawings, like reference number indicate identical or functionallysimilar elements.

FIG. 1 illustrates parts of a crimping system, according to anembodiment.

FIG. 2 illustrates a funnel and barrel of a crimping system, accordingto an embodiment.

FIG. 3 illustrates parts of a crimping system, according to anembodiment.

FIG. 4 illustrates parts of a crimping system, according to anembodiment.

FIG. 5 illustrates parts of a crimping system, according to anembodiment.

FIG. 6 illustrates parts of a crimping system, according to anembodiment.

FIG. 7 illustrates a crimping system, according to an embodiment.

FIG. 8 illustrates parts of a crimping system and a prosthetic valve,according to an embodiment.

FIG. 9 illustrates parts of a crimping system and a prosthetic valveloaded onto a delivery device, according to an embodiment.

FIGS. 10 and 11 illustrate a method of attaching a prosthetic valve to acrimping system, according to an embodiment.

FIGS. 12 and 13 illustrate a method of loading a prosthetic valve into afunnel of a crimping system, according to an embodiment.

FIGS. 14 and 15 illustrate a method of detaching a prosthetic valve froman actuator, according to an embodiment.

FIGS. 16 and 17 illustrate a prosthetic valve loaded into a funnel,according to an embodiment.

FIG. 18 illustrates a method of attaching a prosthetic valve to adelivery device, according to an embodiment.

FIG. 19 illustrates covering a prosthetic valve with an outer sheath ofthe delivery device, according to an embodiment.

FIGS. 20-22 illustrate a method of loading a prosthetic valve within anouter sheath of the delivery device, according to an embodiment.

FIG. 23 illustrates parts of a crimping system and a prosthetic valve,according to an embodiment.

FIG. 24 illustrates a method of attaching a prosthetic valve to acrimping system, according to an embodiment.

FIG. 25 illustrates a method of loading a prosthetic valve into a funnelof crimping system, according to an embodiment.

FIG. 26 illustrates a method of loading a prosthetic valve through afunnel, according to an embodiment.

FIG. 27 illustrates a prosthetic valve loaded on a support tube,according to an embodiment.

FIG. 28 illustrates a method of loading a prosthetic valve onto adelivery device, according to an embodiment.

FIG. 29 illustrates a method of attaching a prosthetic valve to deliverydevice, according to an embodiment.

FIG. 30 illustrates a method of loading a prosthetic valve onto adelivery device, according to an embodiment.

FIG. 31 illustrates a method of loading a prosthetic valve into a funnelattached to a delivery device, according to an embodiment.

FIG. 32 illustrates a prosthetic valve contained within an outer sheathof a delivery device, according to an embodiment.

FIG. 33 illustrates a prosthetic valve attached to a crimping device,according to an embodiment.

FIG. 34 illustrates a prosthetic valve loaded into a funnel of acrimping device system, according to an embodiment.

FIG. 35 illustrates a prosthetic valve being pulled through a funnel ofa crimping device, according to an embodiment.

FIGS. 36-38 illustrate a prosthetic valve being loaded onto a deliverydevice from a crimping system, according to an embodiment.

FIG. 39 illustrates a prosthetic heart valve, according to oneembodiment.

FIG. 40 illustrates a prosthetic heart valve, according to oneembodiment.

DETAILED DESCRIPTION

While the disclosure refers to illustrative embodiments for particularapplications, it should be understood that the disclosure is not limitedthereto. Modifications can be made to the embodiments described hereinwithout departing from the spirit and scope of the present disclosure.Those skilled in the art with access to this disclosure will recognizeadditional modifications, applications, and embodiments within the scopeof this disclosure and additional fields in which the disclosed examplescould be applied. Therefore, the following detailed description is notmeant to be limiting. Further, it is understood that the systems andmethods described below can be implemented in many different embodimentsof hardware. Any actual hardware described is not meant to be limiting.The operation and behavior of the systems and methods presented aredescribed with the understanding that modifications and variations ofthe embodiments are possible given the level of detail presented.

References to “one embodiment,” “an embodiment,” “in certainembodiments,” etc., indicate that the embodiment described may include aparticular feature, structure, or characteristic, but every embodimentmay not necessarily include the particular feature, structure, orcharacteristic. Moreover, such phrases are not necessarily referring tothe same embodiment. Further, when a particular feature, structure, orcharacteristic is described in connection with an embodiment, it issubmitted that it is within the knowledge of one skilled in the art toaffect such feature, structure, or characteristic in connection withother embodiments whether or not explicitly described.

FIG. 1 generally illustrates a crimping system 100, according to anembodiment. Crimping system 100 can include a puller tube 110, which caninclude shaft 112 and tip 114. Tip 114 can include hooks 118 and window116, to which a prosthetic valve can be attached for loading into thecrimping system. Puller tube 110 can be used to pull the prostheticvalve through crimping system 100. Alternatively, and/or additionally,puller tube 110 can be used to hold the prosthetic valve stationarywhile crimping system 100 is advanced over the prosthetic valve.Crimping system 100 can include split step 120. Spilt step may includean outer surface 121 having outer diameter 122 and an interior space 126having first diameter 123 and second diameter 124, the second diameter124 being smaller than the first diameter 123. Interior space 126 canalso include a tapered region 128. Tapered region 128 can facilitatecollapsing the prosthetic valve after it enters first diameter 123 andproceeds towards second diameter 124. In other words, tapered region 128allows split step 120 to crimp the prosthetic valve. Interior space 126may also include a straight section 125 located between tapered region128 and second diameter 124 (see FIG. 6 ).

Crimping system 100 can also include a barrel 130 having an exteriorsurface 132 and interior diameter 134. Barrel 130 can include anattachment portion 136, which can include one or more protrusions 138.In certain embodiments, attachment portion 136 can include one or moreindentations, in addition to, or instead of, protrusions 138. Crimpingsystem 100 can also include a funnel 140 having an outer surface 141 andan inner surface 143. Inner surface 143 may have a first diameter 144and a second diameter 142 separated by a tapered region 146, the seconddiameter 142 being smaller than the first diameter 144. The firstdiameter 144 of funnel 140 also being larger than the first diameter 123of split step 120. Funnel 140 can also include an attachment portion 148having one or more protrusions 138 for releasably engaging protrusions138 on attachment portion 136. In certain embodiments, attachmentportion 148 can include one or more indentations, in addition to, orinstead of, protrusions 138. Protrusions 138 on attachment portions 136and 148 of barrel 130 and funnel 140, respectively, can facilitatemating of barrel 130 to funnel 140. In certain embodiments, attachmentportions 136 and 148 may include a luer-lock attachment configuration.In some embodiments, the second diameter 142 of funnel 140 is the sameas first diameter 123 of split step 120.

FIG. 2 illustrates funnel 140, having second diameter 142, firstdiameter 144, tapered region 146, and attachment portion 148. FIG. 2also illustrates barrel 130, having exterior surface 132, interiordiameter 134, attachment portion 136, and protrusion 138. As shown inFIG. 2 , funnel 140 can be connected to barrel 130. Funnel 140 can beconnected to barrel 130 by a variety of means. For example, funnel 140can be press-fit into barrel 130 such that attachment portion 148 offunnel 140 mates with attachment portion 136 of barrel 130. In certainembodiments, one or more protrusions 138 on attachment portion 136 ofbarrel 130 can interact with one or more protrusions 138 or indentationsof attachment portion 148 of funnel 140. In certain embodiments, funnel140 and barrel 130 can be twisted in order to have protrusions 138 lockbarrel 130 and funnel 140 together. In certain embodiments, barrel 130and funnel 140 can be correspondingly threaded such that the componentscan be mated by rotating them in opposite directions.

FIG. 3 illustrates puller tube 110, which can include shaft 112, tip114, window 116, and hooks 118. FIG. 3 also illustrates barrel 130 andfunnel 140, having parts corresponding to those described above withrespect to FIG. 2 . Puller tube 110 can be inserted through interiordiameter 134 of barrel 130 and through funnel 140. Tip 114 of pullertube 110 can extend out of firstdiameter 144 of funnel 140 for easyattachment to a valve prosthesis.

In certain embodiments, the valve prosthesis (not shown) can be attachedto tip 114 of puller tube 110 using hooks 118 and window 116. In certainembodiments, one or more portions of the frame of theprosthesis can beattached to hooks 118 and held within window 116. In certainembodiments, support arms of the prosthesis can be attached to hooks 118and held within window 116. Hooks 118 and window 116 can have variousshapes and configurations designed to retain the valve prosthesis andare not limited to the configurations shown in the Figures.

In certain embodiments, after the prosthetic valve is connected topuller tube 110, funnel 140 can be advanced over the prosthetic valve(or the prosthetic valve can be pulled into funnel 140 using puller tube110) such that the prosthetic valve enters first diameter 144 of funnel140 and proceeds into tapered region 146, where the prosthetic valve canbe compressed. Funnel 140 can be further advanced such that theprosthetic valve enters second diameter 142 of funnel 140 and proceedsinto interior diameter 134 of barrel 130. Once the prosthetic valve islocated within interior diameter 134 of barrel 130, funnel 140 can bedisconnected from barrel 130, as shown, for example, in FIG. 4 . In someembodiments, interior diameter 134 of barrel 130 is equal to the seconddiameter 142 of funnel 140. In some embodiments, the length of barrel130 is such that is it capable of housing the entire valve prosthesis.

FIGS. 5 and 6 illustrate split step 120, which can be used to furtherdecrease the loading diameter of the valve prosthesis. In certainembodiments, split step 120 can be attached to barrel 130 after funnel140 is disconnected from barrel 130. Delivery device tip 150 isillustrated as a reference point to indicate the distal end of thedelivery device (not shown), about which the prosthetic valve can beloaded. In certain embodiments, split step 120 can be fitted aboutbarrel 130. For example, first diameter 123 of split step 120 can besized to fit about exterior surface 132 of barrel 130. Split step 120may be configured to split into two pieces as shown in FIG. 5 . Thisallows split step 120 to be fitted about exterior surface 132 of barrel130 when a delivery device is present and extending through barrel 130.This also allows split step 120 to be fitted about exterior surface 132of barrel 130 when puller tube 110 is attached to the valve prosthesisand extending through second diameter 124. Preferably, second diameter124 and/or the diameter of straight section 125 of split step 120 aresmaller than second diameter 142 of funnel 140 and interior diameter 134of barrel 130. This allows the prosthetic valve to be further crimped bysplit step 120 before it is loaded onto the delivery device.

In certain embodiments, the delivery device can be manipulated to movean outer sheath 151 in the distal direction, as indicated by the arrowin FIG. 6 . This can, in turn, advance split step 120 and barrel 130 inthe distal direction, enabling the prosthetic valve to enter split step120 through first diameter 123 and move through interior space 126 andtapered region 128 of split step 120. Second diameter 124 may beconfigured to receive at least a portion of outer sheath 151. As outersheath 151 is moved in the distal direction, outer sheath 151 receivesvalve prosthesis from straight section 125. In certain embodiments,outer sheath 151 can have a diameter approximately equal to seconddiameter 124 of split step 120, and a distal end of outer sheath 151 canbe fitted against a shoulder 127 created by straight section 125 andsecond diameter 124 to allow the prosthesis to smoothly enter into outersheath 151. After the outer sheath 151 has received the entire valveprosthesis, split step 120 and barrel 130 can be removed from thedelivery device, leaving the valve prosthesis encapsulated within outersheath 151 of the delivery device with tip 150 sealing the end of outersheath 151. In certain embodiments, outer sheath 151 can slide withinsplit step 120 and barrel 130 to encapsulate the valve prosthesis. Insuch embodiments, the outer sheath 151 can have a diameter approximatelyequal to or less than the diameter of straight section 125 and interiordiameter 134 of barrel 130.

In general terms the “valve prosthesis” or “prosthetic valve” of thepresent disclosure includes a stent or stent frame maintaining a valvestructure (tissue or synthetic), with the stent having a natural ornormal, expanded arrangement and collapsible to a compressed arrangementfor loading within a delivery device. The stent is normally constructedto self-deploy or self-expand when released from a delivery device. Forexample, the stented prosthetic heart valve useful with the presentdisclosure can be a prosthetic valve sold under the trade nameCoreValve® available from Medtronic CoreValve, LLC. Other non-limitingexamples of transcatheter heart valve prostheses useful with systems,devices, and methods of the present disclosure are described in U.S.Publication Nos. 2006/0265056; 2007/0239266; and 2007/0239269, theteachings of each which are incorporated herein by reference. Anothernon-limiting example of prosthetic valves that may be used in accordancewith one or more embodiments of the devices and methods of the presentdisclosure are described in more detail in U.S. patent application Ser.No. 14/175,100, filed on Feb. 7, 2014, entitled HEART VALVE PROSTHESIS,which is incorporated herein by reference. The stents or stent framesare support structures that comprise a number of struts or wire portionsarranged relative to each other to provide a desired compressibility andstrength to the prosthetic heart valve. In general terms, the stents orstent frames of the present disclosure are generally tubular supportstructures having an internal area in which valve structure leafletswill be secured. The leaflets can be formed from a verity of materials,such as autologous tissue, xenograph material, or synthetics as areknown in the art. The leaflets may be provided as a homogenous,biological valve structure, such as porcine, bovine, or equine valves.Alternatively, the leaflets can be provided independent of one another(e.g., bovine or equine paracardial leaflets) and subsequently assembledto the support structure of the stent frame. In another alternative, thestent frame and leaflets can be fabricated at the same time, such as maybe accomplished using high-strength nano-manufactured NiTi filmsproduced at Advance BioProsthetic Surfaces (ABPS), for example. Thestent frame support structures are generally configured to accommodateat least two (typically three) leaftlets; however, replacementprosthetic heart valves of the types described herein can incorporatemore or less than three leaflets.

Some embodiments of the stent frames can be a series of wires or wiresegments arranged such that they are capable of self-transitioning fromthe compressed or collapsed arrangement to the normal, radially expandedarrangement. In some constructions, a number of individual wirescomprising the stent frame support structure can be formed of a metal orother material. These wires are arranged in such a way that the stentframe support structure allows for folding or compressing or crimping tothe compressed arrangement in which the internal diameter is smallerthan the internal diameter when in the natural, expanded arrangement. Inthe collapsed arrangement, such a stent frame support structure withattached valves can be mounted onto a delivery device. The stent framesupport structures are configured so that they can be changed to theirnatural, expanded arrangement when desired, such as by the relativemovement of one or more sheaths relative to a length of the stent frame.

The wires of the stent frame support structures in embodiments of thepresent disclosure can be formed from a shape memory material such as anickel titanium alloy (e.g., Nitinol™). With this material, the supportstructure is self-expandable from the compressed arrangement to thenatural, expanded arrangement, such as by the application of heat,energy, and the like, or by the removal of external forces (e.g.,compressive forces). This stent frame support structure can also becompressed and re-expanded multiple times without damaging the structureof the stent frame. In addition, the stent frame support structure ofsuch an embodiment may be laser-cut from a single piece of material ormay be assembled from a number of different components. For these typesof stent frame structures, one example of a delivery device that can beused includes a catheter with a retractable sheath that covers the stentframe until it is to be deployed, at which point the sheath can beretracted to allow the stent frame to self-expand.

FIGS. 7-22 illustrate a crimping system, according to an embodiment.FIG. 7 illustrates a crimping system 200, which can include a handle 240having a channel 242 and a pull ring 230. Handle 240 may be configuredto receive at least a portion of a delivery device 250. Crimping system200 can include a small funnel 220 having an outer surface 221 and aninner surface 223. Inner surface 223 can have first diameter 222 and asecond diameter 224 separated by a tapered region 226, the seconddiameter 224 being smaller than the first diameter 222. Crimping system200 can also include a large funnel 210 having outer surface 211 and aninner surface 213. The term “large” meaning that at least a portion ofinner surface 213 has a diameter larger than the largest diameter ofinner surface 223 of small funnel 220. Inner surface 213 can include afirst diameter 212 and a second diameter 214 separated by a taperedregion 216, the second diameter 214 being smaller than the firstdiameter 212. Preferably, first diameter 212 of large funnel 210 islarger than first diameter 222 of small funnel 220. In certainembodiments, second diameter 214 of large funnel 210 can be sized tomate with and directly connect to second diameter 224 of small funnel220. In some embodiments, second diameter 214 of large funnel 210 isequal to second diameter 224 of small funnel 220.

FIG. 8 shows a deconstructed parts assembly of crimping system 200,according to an embodiment. Handle 240 can include a body 244 and anelongated portion 241 connected via a shoulder 243. Pull ring 230 can beslidably disposed on elongated portion 241. Elongated portion 241 caninclude a distal end configure to engage first diameter 222 of smallfunnel 220. Handle 240 can include channel 242 extending through andlocated on elongated portion 241, from which pull wires 232 can beextend. In certain embodiments, pull wires 232 can have hooks 234located at an end of pull wires 232. Pull wires 232 can be operativelyconnected to pull ring 230 such that pull ring 230 can retract andextend pull wires 232 into and out of elongated portion 241 and channel242. FIG. 8 also illustrates small funnel 220 having a hollow shapedefined by first diameter 222, second diameter 224, and tapered region226. As shown in FIG. 8 , large funnel 210 can include a hollow shapedefined by first diameter 212, second diameter 214, and tapered region216 (shown in FIG. 7 ).

FIG. 8 also illustrates a prosthetic valve 260, according to anembodiment. Prosthetic valve 260 can include a frame 262 and a valveportion 264. FIG. 8 further illustrates delivery device 250, accordingto an embodiment. Delivery device 250 can include an outer sheath 258, astrut support 256, an inner shaft 254, and a tip 252.

FIG. 9 illustrates prosthetic valve 260, large funnel 210, and smallfunnel 220 loaded onto delivery device 250 having outer sheath 258located at a proximal end and tip 252 located at a distal end. Smallfunnel 220 can be moved along delivery device 250 to be fitted againstor within large funnel 210.

FIGS. 10 and 11 illustrate a method of attaching prosthetic valve 260 tothe handle 240, according to an embodiment. As shown in FIG. 12 , distalend 231 of elongated portion 241 can engage first diameter 222 of smallfunnel 220. Pull wires 232 can be compressed and inserted through smallfunnel 220 and large funnel 210. Pull ring 230 may be configured toextend pull wires 232 out of distal end 231, through small funnel 220and through large funnel 210. Prosthetic valve 260 can be moved alongouter sheath 258 until at least a portion of the prosthetic valve is inthe vicinity of pull wires 232, e.g., until support arms 263 ofprosthetic valve 260 are in the vicinity of pull wires 232 (as shown inFIG. 11 ). A portion of frame 262, e.g., support arms 263 can beattached to hooks 234 of pull wires 232, for example, by folding supportarms 263 in the distal direction.

FIGS. 12-22 illustrate the crimping process, according to an embodiment.In certain embodiments, once hooks 234 of pull wires 232 are attached tosupport arms 263, pull ring 230 can be moved in a direction away fromlarge funnel 210 such that prosthetic valve 260 is pulled into largefunnel 210 through first diameter 212, as shown, for example, in FIG. 12. In certain embodiments, as shown, for example, in FIG. 13 , tabs 266of frame 262 can be positioned about strut support 256 and landing zone257 of delivery device 250. As shown in FIG. 14 , in certainembodiments, pull ring 230 can be moved along handle 240 in a directionfurther away from large funnel 210 and small funnel 220, as indicated bythe arrow. In certain embodiments, a stopper can be included in or onhandle 240 to stop pull ring 230 at a certain location. In someembodiments, shoulder 243 can serve as the stopper. Pull ring 230 can bemoved away from large funnel 210 and small funnel 220 until prostheticvalve 260 is be located at least partially within small funnel 220. Incertain embodiments, a portion of frame 262 such as support arms 263 canextend out of small funnel 220 and into channel 242 of handle 240. Pullring 230 can then be advanced toward small funnel 220 in order torelease hooks 234 of pull wires 232 from support arms 263 of frame 262of prosthetic valve 260. In certain embodiments, pull wires 232 can bemanually released from support arms 263 of frame 262.

As shown in FIG. 16 , once hooks 234 of pull wires 232 are released fromsupport arms 263 of frame 262, handle 240 can be removed, leavingsupport arms 263 of frame 262 exposed out of first diameter 222 andtapered region 226 of small funnel 220. The majority of prosthetic valve260 can be constrained within second diameter 224 of small funnel 220.As shown, for example, in FIG. 17 , large funnel 210 can also be removedby sliding it along delivery device 250 in the direction indicated bythe arrows. This can leave prosthetic valve 260 loaded within smallfunnel 220 with frame 262 partially exposed. After large funnel 210 isremoved frame 262 of prosthetic valve 260 can remain compressed andfrictionally engaged to small funnel 220 and/or strut support 256. Insuch embodiments, frame 262 can be collapsed about strut support 256 soas to engage strut support 256 and/or landing zone 257. Tabs 266 can bealigned with landing zone 257. In certain embodiments, tabs 266 of frame262 can be attached to landing zone 257 using for example, but notlimited to, a tongue and groove mechanism, a keyhole and pin mechanism,a hook and releasable lanyard mechanism or similar mechanisms. Onceprosthetic valve 260 is secured to delivery device 250, outer sheath 258can be moved over landing zone 257, tabs 266, and frame 262 ofprosthetic valve 260 in the direction indicated by the arrow in FIG. 19.

FIGS. 20-22 illustrate the completion of loading prosthetic valve 260within outer sheath 258 according to one embodiment. As shown in FIG. 20, outer sheath 258 can be advanced through small funnel 220 and out offirst diameter 222 to further constrain prosthetic valve 260. Smallfunnel 220 can be removed in an opposite direction to uncover andvisualize prosthetic valve 260. In FIG. 20 , support arms 263 are shownin an unconstrained configuration. FIG. 21 illustrates support arms 263being collapsed and enclosed within outer sheath 258. Finally, FIG. 22illustrates the entire prosthetic valve 260 encapsulated within outersheath 258 as outer sheath 258 reaches tip 252 of delivery device 250.

FIGS. 23-32 illustrate a crimping system 300, according to anembodiment. Crimping system 300 can include a puller tube 310 having ashaft 312 and one or more hooks 318. Crimping system 300 can include asmall funnel 320 having a through hole 324 extending from a proximal end321 to a distal end 323. Proximal end 321 can have a first innerdiameter and distal end 323 can have a second inner diameter, the firstinner diameter being separated from the second inner diameter by taperedregion 236 and the first inner diameter being larger than the secondinner diameter. Small funnel 320 can include a small tube 322 releasablyattached to distal end 323 via one or more attachment members 328.Crimping system 300 can include a large funnel 330 having a through hole334 extending from a proximal end 331 to a distal end 333. Proximal end331 can have a first inner diameter and distal end 333 can have a secondinner diameter, the first inner diameter and the second inner diameterbeing separated by a tapered region 336 and the first inner diameterbeing larger than the second inner diameter. Compared to small funnel320, at least a portion of the interior diameter of large funnel 330 islarger than the largest interior diameter of small funnel 320.Preferably, proximal end 331 of large funnel 330 has an inner diameterthat is larger than the inner diameter of proximal end 321 of smallfunnel 320. Large funnel 330 can include a large tube 332 releasablyattached to distal end 333 via one or more attachment members 338. Largetube 332 has a larger inner diameter than the inner diameter of smalltube 322. Crimping system 300 can also include a support tube 340. Alsoshown in FIG. 23 is a delivery device 350, according to an embodiment.Delivery device 350 can include outer sheath 358, landing zone 357,inner shaft 354, and tip 352. FIG. 23 also shows a prosthetic valve 360having frame 362 and valve portion 364.

While FIG. 23 shows attachment members 328 and 338 attached to theexterior of small funnel 320 and large funnel 330, small funnel 320 andlarge funnel 330 can include any type of known releasable attachmentmeans. For example, but not limited to, small funnel 320 and largefunnel 330 can include screw threads, luer-locks, snap-fittingmechanisms, etc.

FIG. 24 illustrates prosthetic valve 360 with support arms 363 extendingfrom frame 362 and attached to hooks 318 of shaft 312. Shaft 312 canextend through large funnel 330 and large tube 332, and out of proximalend 331. Shaft 312 can be used to pull prosthetic valve 360 intoproximal end 331 of large funnel 330 and further into tapered region 336until prosthetic valve 360 enters large tube 332. As shown in FIG. 25 ,support tube 340 can be inserted through valve portion 364 of prostheticvalve 360 and into large funnel 330 and large tube 332. Prosthetic valve360 can be pulled through proximal end 331 of large funnel 330, throughtapered region 336, and into large tube 332. This can collapseprosthetic valve 360 about support tube 340 until support arms 363 ofprosthetic valve 360 are through large tube 332, as shown in FIG. 26 .Then, support arms 363 can be disconnected from hooks 318 of shaft 312,and shaft 312 and large funnel 330 can be removed, as shown, forexample, in FIG. 27 . Once shaft 312 and large funnel 330 are removed,support arms 363 can be allowed to fold back into their native position.Frame 362 of prosthetic valve 360 can generally be located within largetube 332 and about support tube 340. Support tube 340 and/or large tube332 can be used to hold prosthetic valve 360 in a partially crimpedconfiguration. In some embodiments, as shown in FIGS. 27 and 28 , largetube 332 has a length such that at least a portion of prosthetic valve360 extends from both ends of large tube 332.

As shown in FIG. 28 , in some embodiments, small funnel 320 and smalltube 322 can be loaded over delivery device 350. Delivery device 350with small funnel 320 and small tube 322 loaded thereon can then beattached to large tube 332 to further crimp prosthetic valve 360. Tip352 of delivery device 350 can be inserted through the interior of frame362, large tube 332, and support tube 340. As shown, for example, inFIG. 29 , delivery device 350 can be advanced until landing zone 357engages a portion of prosthetic valve 360, e.g., tabs 366 of frame 362near large tube 332. In some embodiments, tabs 366 can be attached tolanding zone 357. In certain embodiments, tabs 366 of frame 362 can beattached to landing zone 357 using for example, but not limited to, atongue and groove mechanism, a keyhole and pin mechanism, a hook andreleasable lanyard mechanism, or similar mechanisms. Once a portion ofprosthetic valve 360 is attached to landing zone 357, outer sheath 358can be advanced over at least a portion of frame 362. As shown in FIG.30 , outer sheath 358 can be advanced over landing zone 357 and tabs 366to secure frame 362 on delivery device 350. As shown in FIG. 30 ,support tube 340 can be removed over tip 352, leaving frame 362constrained within large tube 332.

As shown in FIG. 31 , small funnel 320 can be advanced, which candisplace large tube 332 such that prosthetic valve 360 moves throughproximal end 321, into tapered region 326 of small funnel 320, and theninto small tube 322. As small funnel 320 is advanced over prostheticvalve 360 (or prosthetic valve 360 is pulled through small funnel 320),prosthetic valve 360 is further crimped and prosthetic valve 360 isforced into small tube 322. As shown in FIG. 32 , outer sheath 358 canbe advanced to tip 352 of delivery device 350 to fully encapsulateprosthetic valve 360 and support arms 363 within outer sheath 358 and sothat small tube 322 can be removed.

FIGS. 33-38 illustrate crimping system 400, according to an embodiment.Crimping system 400 can include a large funnel 430 having a through hole434 defined by a proximal end 431 having a first diameter and a distalend 433 having a second diameter, proximal end 431 and distal end 433separated by a tapered region 436 and the first diameter being largerthan the second diameter. As shown, for example, in FIG. 33 , a portionof prosthetic valve 460, e.g., support arms 463 extending from frame 462of prosthetic valve 460 can be threaded with suture 440 in preparationfor loading into through hole 434 and tapered region 436 of large funnel430. As shown in FIG. 34 , large funnel 430 can be placed over deliverydevice 450 which can include tip 452, inner shaft 454, retaining tube456, and outer sheath 458. Then, prosthetic valve 460 can be pulled intolarge funnel 430 using sutures 440. Alternatively, large funnel 430 canbe advanced over prosthetic valve 460 while maintaining tension onsutures 440. As large funnel 430 is advanced over prosthetic valve 460(or prosthetic valve 460 is pulled through large funnel 430), prostheticvalve 460 is crimped.

As shown in FIG. 35 , while in funnel 430, a portion of prosthetic valve460 can be arranged about landing zone 457. Prosthetic valve 460 can beattached to delivery system in a similar fashion as described above inreference to FIGS. 28-30 and then outer sheath 458 can be advanced tocover landing zone 457 and a portion of prosthetic valve 460. Afterprosthetic valve 460 is attached, prosthetic valve 460 can be pulledwithin retaining tube 456 as illustrated in FIGS. 36 and 37 . Then, asillustrated in FIG. 38 , funnel 430 can be removed leaving prostheticvalve 460 within retaining tube 456. Retaining tube 456 can have afunnel-like shape defined by a proximal end 451 having a first diameterand a distal end 453 having a second diameter. Proximal end 451 anddistal end 453 may be separated by a tapered region 455 with the firstdiameter being larger than the second diameter. Preferably, the firstdiameter of proximal end 451 is smaller than the first diameter atproximal end 431 of large funnel 430. Preferably, the first diameter ofproximal end 451 is smaller than the second diameter of large funnel 430at distal end 433, such that retaining tube 456 can slide through largefunnel 430. As retaining tube 456 is passed over prosthetic valve 460(or prosthetic valve is pulled through retaining tube 456) prostheticvalve may be further crimped. Then, outer sheath 458 can be slid overprosthetic valve 460 until outer sheath 458 reaches tip 452 of deliverydevice 450, encapsulating prosthetic valve 460 within outer sheath 458.

The system components described herein can be made from a variety ofmaterials known in the art. These include, but are not limited to,stainless steel, nitinol, plastics, polymers, composites, and any othersuitable material.

Prosthetic valves as used in accordance with the devices and methods ofthe present disclosure can be generally used for replacement of a nativeaortic, mitral, pulmonic, or tricuspid valve, for use as a venous valve,or to replace a failed bioprosthesis. FIGS. 39 and 40 illustrate aprosthetic valve 560, according to one embodiment, that may be used inaccordance with the devices and methods of the present disclosure.Prosthetic valve 560 can include a stent or stent frame 562 maintaininga valve structure (tissue or synthetic) 564. Frame 562 can include aninlet or inflow portion 567, a central portion 568, and an outlet oroutflow portion 569. Frame 562 can include one or more tabs 566. Frame562 can have an expanded arrangement for maintaining the prostheticvalve 560 in a desired implant location and a crimped, collapsed orcompressed arrangement for loading within a delivery system. In certainembodiments, prosthetic valve 560 may or may not comprise one or moresupport arms 563.

The crimping systems according to various embodiments described hereinprovide for multi-component modular crimping systems with componentsthat can be easily and reversibly connected via releasable attachmentmechanisms. The releasably attached components provide for easilycleaning of the crimping system. Also, in the event that one of thecomponents becomes damaged, that component can be easily replaced. Thereleasable and interchangeable nature of the components of the crimpingsystems described herein also allow for easy transport and reduce thespace needed to perform a crimping operation. Additionally, the modularcomponents of the crimping systems allow for a specific component to beinterchanged with a component having an improved design and/or differentsize to accommodate future needs.

The foregoing description has been presented for purposes ofillustration and description. It is not intended to be exhaustive or tolimit the precise embodiments disclosed. Other modifications andvariations may be possible in light of the above teachings. Theembodiments and examples were chosen and described in order to bestexplain the principles of the embodiments and their practicalapplication, and to thereby enable others skilled in the art to bestutilize the various embodiments with modifications as are suited to theparticular use contemplated. By applying knowledge within the skill ofthe art, others can readily modify and/or adapt for various applicationssuch specific embodiments, without undue experimentation, withoutdeparting from the general concept. Therefore, such adaptations andmodifications are intended to be within the meaning and range ofequivalents of the disclosed embodiments, based on the teaching andguidance presented herein.

1-31. (canceled)
 32. A system for crimping a prosthetic valvecomprising: a funnel having a first funnel diameter, a tapered funnelregion, and a second funnel diameter smaller than the first funneldiameter; a retaining tube having a first tube diameter at a proximalend and a second tube diameter at a distal end, the second tube diametersmaller than the first tube diameter, and the first tube diametersmaller than the second funnel diameter; and a delivery deviceincluding: a distal tip, an inner shaft, and an outer sheath having asheath diameter smaller than the second tube diameter; wherein thefunnel is configured to provide a first crimping of the prostheticvalve, the retaining tube is configured to provide a second crimping ofthe prosthetic valve that is smaller than the first crimping, and theouter sheath is configured to provide a third crimping of the prostheticvalve that is smaller than the second crimping.
 33. The system of claim32, wherein the funnel is configured to crimp the prosthetic valve tothe second funnel diameter when the prosthetic valve is pulled throughfunnel in the first crimping, the retaining tube is configured to crimpthe prosthetic valve to the second tube diameter when the prostheticvalve is pulled through the retaining tube in the second crimping, andthe outer sheath is configured to encapsulate the prosthetic valvewithin the sheath diameter in the third crimping.
 34. The system ofclaim 32, further comprising sutures configured for attachment tosupport arms extending from a frame of the prosthetic valve.
 35. Thesystem of claim 34, wherein the sutures are further configured tosuccessively pull the prosthetic valve into the funnel and the retainingtube.
 36. The system of claim 34, wherein the sutures are furtherconfigured to maintain tension on the prosthetic valve while the funnel,the retaining tube, and the outer sheath are successively passed overthe prosthetic valve.
 37. The system of claim 32, wherein the retainingtube is concentrically aligned and slidable within a through hole of thefunnel.
 38. The system of claim 32, wherein the retaining tube includesa tapered tube region between the first tube diameter and the secondtube diameter.
 39. The system of claim 38, wherein the tapered tuberegion and the tapered funnel region taper in a direction toward thedistal tip.
 40. A method for crimping a prosthetic valve comprising:advancing the prosthetic valve into a funnel to provide a first crimpingof the prosthetic valve, the funnel having a first funnel diameter, atapered funnel region, and a second funnel diameter smaller than thefirst funnel diameter; arranging the prosthetic valve over a landingzone of an inner shaft of a delivery device; advancing the prostheticvalve into a retaining tube to provide a second crimping of theprosthetic valve, the retaining tube having a first tube diameter at aproximal end and a second tube diameter at a distal end, the second tubediameter smaller than the first tube diameter, and the first tubediameter smaller than the second funnel diameter; removing the funnelfrom around the prosthetic valve; advancing the prosthetic valve into anouter sheath of the delivery device to provide a third crimping of theprosthetic valve, the outer sheath having asheath diameter smaller thanthe second tube diameter; and removing the retaining tube from aroundthe prosthetic valve.
 41. The method of claim 40, further comprisingattaching the prosthetic valve to the inner shaft at the landing zone.42. The method of claim 40, further comprising attaching sutures tosupport arms extending from a frame of the prosthetic valve.
 43. Themethod of claim 42, further comprising: advancing the prosthetic valveinto the funnel by pulling the prosthetic valve with the sutures; andadvancing the prosthetic valve into the retaining tube by pulling theprosthetic valve with the sutures.
 44. The method of claim 42, furthercomprising: advancing the prosthetic valve into the funnel bymaintaining tension on the prosthetic valve with the sutures while thefunnel is advanced over the prosthetic valve; advancing the prostheticvalve into the retaining tube by maintaining tension on the prostheticvalve with the sutures while the retaining tube is advanced over theprosthetic valve; and maintaining tension on the prosthetic valve withthe sutures while the outer sheath is advanced over the prostheticvalve.